Snapshot

The Extraordinary Use New Drugs (EUNDs) pathway has been developed by the of Canada.

This pathway can be used where Extraordinary Use New Drugs (EUND) .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

The projected review times are 300 days for EUNDS, 180 days for AEUNDS, 300 days for SEUNDS and 300 days for SAEUNDS, the same as for NDSs, ANDSs, SNDSs and SANDs. Should there be an immediate need for an EUND, Health Canada may consider an expedited review of the submission.